About the Company
The Pharmacy Compliance Quality Systems Analyst supports the Senior Director of Compliance in maintaining regulatory compliance, inspection readiness, and Quality Management System (QMS) integrity across multiple 503A compounding pharmacies operating in Texas, California, and Alabama.
About the Role
This role functions as the operational backbone of the compliance program and is responsible for CAPA management, audit coordination, documentation control, licensing support, training oversight, and cross-site regulatory standardization under USP, USP, USP, USP, state Board of Pharmacy regulations, and FDA guidance for 503A pharmacies.
Responsibilities
- Facilitate CAPA initiation, root cause analysis (RCA), and effectiveness checks
- Own and maintain the Master CAPA Tracker across all sites
- Track closure timelines and escalate overdue actions
- Maintain inspection-ready documentation binders (electronic + site-specific)
- Coordinate mock inspections (Texas BOP, CA BOP, AL BOP, FDA)
- Track remediation items from board inspections
- Maintain board correspondence files
- Support DEA, state, and non-resident PIC license tracking
- Maintain Pharmacy Network License Workup tracker
- Track pharmacist, technician, and trainee licenses
- Monitor supervision ratios
- Track non-resident pharmacy licensing requirements
- Monitor renewal deadlines and documentation completeness
- Maintain sterile compounding competency tracker
- Assist with training documentation standardization across all sites
- Monitor new hire onboarding compliance
- Maintain master SOP index
- Ensure SOP alignment across multiple states
- Ensure document version control integrity
This position may assume additional responsibilities as required to meet organizational objectives and support operational priorities.
Qualifications
- Required:
- Bachelor’s degree in science, pharmacy, regulatory affairs, or healthcare administration
- 5+ years experience in pharmacy compliance, sterile compounding, or healthcare quality systems
- Working knowledge of USP, USP
- Strong Excel and data analysis skills
- Experience with CAPA and QMS systems
- Strong analytical and documentation skills
- Preferred:
- 503A and/or 503B sterile compounding experience
- Multi-state regulatory exposure
- Experience preparing for board or FDA inspections
- Certification in Quality or Regulatory Affairs (CQA, RAC, etc.)
